NCT00827736View on ClinicalTrials.gov

Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

PHASE4CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

June 30, 2002

Primary Completion Date

March 31, 2006

Study Completion Date

March 31, 2006

Conditions
Anal Fissure
Interventions
PROCEDURE

Botox

injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.

DRUG

ISDN ointment

application of ISDN 1% ointment 6 times a day

DRUG

Placebo

"Injection of placebo into internal anal sphincter (ISDN ointment arm)~Applied to the anoderm six times a day (Botox injection arm)"

Trial Locations (1)

1090 HM

Onze Lieve Vrouwe Gasthuis, Amsterdam

All Listed Sponsors
lead

Onze Lieve Vrouwe Gasthuis

OTHER

NCT00827736 - Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure | Biotech Hunter | Biotech Hunter